The right to consent: Is it absolute?

Abstract Informed consent is required for all medical investigations and procedures and is considered a corner stone of modern medicine. This review article examines the question whether the right to consent is absolute by looking at the philosophical, ethical and legal principles underlying consent. There are several legal exceptions to the right of consent in the United Kingdom concerning minors, incapacitated patients, patients with mental illness and patients suffering from communicable diseases. Furthermore the practical implications of consent and shortcomings of informed consent are discussed as well as the concept of advanced directives and lasting powers of attorneys. While a patient has a right to refuse treatment (all exceptions are discussed), there is no legal right to demand treatment in the United Kingdom.

The patient's
right to autonomy should always be respected and steps shall be taken
to make consent truly informed. There is, however, no absolute right
to consent on the basis of philosophical, ethical, legal and practical
considerations.

Introduction

Consent
to investigations and treatment is considered a cornerstone in the doctor-patient
relationship.1 The Oxford Dictionary (1998) defines consent
as “permission for something to happen or agreement to do something”.2
This definition does not entail understanding of the action agreed to
and for medical purposes the term ”informed consent” meaning “permission
granted in the knowledge of possible consequences” has been developed.2
General Medical Council (GMC) guidance requires the ability to comprehend
and weigh up information as well the ability to communicate for informed
consent.3

Most authors
describe consent as a principle relatively new to medicine.4-6
This is however incorrect as even Plato and Hippocrates used consent
in their medical practice.7

This review
addresses the issue whether the right to consent is an absolute right
by exploring the ethical and legal framework of consent or more specifically
informed consent. Whereas most of the ethical issues are universally
applicable, the legal aspects and guidance by the regulatory authorities
apply only to the United Kingdom (UK). Where law differs between Scotland
and the rest of the UK, I have focused on the laws for the latter.

Ethical
principles around consent

The four
main principles of medical ethics are justice, non-malificence, autonomy
and beneficence.8 Autonomy is the main ethical consideration
underlying informed consent. The patients’ right to determine what
investigations and treatment to undergo must be respected by all doctors.3
For consent to be informed patients rely on the information provided
by their doctor. Honesty and truthfulness are required to make the process
of consent valid.3 The ethical principle of justice needs
to be applied when deciding what treatments are offered to or withheld
from patients. This touches the process of informed consent and is further
explored when the right to demand certain treatments is discussed.

Philosophical
aspects

The debate
whether a right or a principle is absolute not only involves ethical
and legal aspects. It also touches on the philosophical argument of
absoluteness. Freedom as an example can’t exist as an absolute principle
because granting one individual absolute freedom will infringe the freedom
of a second individual considerably. Person A’s freedom to take any
good will influence the freedom of person B to have property. When applying
these principles to autonomy the same problem arises: Total autonomy
of one individual has a negative effect on autonomy of other individuals.
The modern democratic society has designed rules and laws to create
a fair way of living. On the one hand this restricts autonomy, while
on the other hand this same restricted autonomy guarantees the same
amount of it to all members of this society.

I argue
therefore that on a philosophical basis the principle of total autonomy
contradicts itself when applied to society. As autonomy is the main
ethical principle for informed consent an absolute right to consent
cannot exist.

Requirements
of informed consent

The basic
difference between consent and informed consent is the patients’ knowledge
behind the consent decision. Informed consent requires the patient to
understand the diagnosis and uncertainties about it as well as the different
treatment options (including doing nothing) and their advantages, disadvantages
and achievable outcomes.3 The amount of information required
to make consent informed may vary depending on complexity and risks
of treatment as well as the patient’s wishes.3 Furthermore
individual patients will have different intellectual capabilities and
understanding of their illness. It is therefore mandatory to tailor
information provided to the individual patient and the current situation.
An emergency like acute myocardial infarction for example will allow
less time to discuss diagnosis and treatment than an elective endoscopy.

To judge
whether a patient has really understood the information provided can
be difficult and often little of the information is retained (see practical
aspects chapter). This leaves physicians in doubt whether their patient’s
consent is truly informed. Consent based on partial information may
be invalid but this may go unnoticed by patient and treating physician.

The principal
of an absolute right to consent could be easily undermined by partial
information. It is highly dependant on the willingness to provide full
information and the patient’s capability to understand it and weigh
up the options.

Legal
framework

A medical
intervention without valid informed consent is a criminal offence and
the physician can be charged with battery. Examples of such situations
include treatment against the patient’s will, different treatment
than the one consented for and treatment after consenting deliberately
with wrong information.9

Guidance
for consent has been set up by the regulatory body (GMC). While no one
can consent for a competent adult UK laws are regulating consent for
minors, patients with acutely or permanent incapacity and patients suffering
form severe mental illness.

Minors

At the age
of 16 persons are to be considered as adults and can therefore be presumed
to have capacity. Children younger than 16 years may have capacity depending
on their understanding. When a competent child refuses treatment persons
with parental responsibility may authorise this or a court may overrule
the child’s decision.3 Incompetent children will be treated
with consent from a person with parental responsibility.

Acute
and permanent incapacity

The presumption
that every adult patient has capacity applies unless the opposite can
be clearly demonstrated.3, 10 Patients lacking capacity due
to an acute (i.e loss of consciousness after an accident or patients
on mechanical ventilation) or chronic illness (i.e dementia) cannot
make decisions about their treatments themselves. In those situations
it is the doctor’s duty to act in the “best interest of the patient”.
Views about the patient’s preferences may be sourced from a third
party (relatives for example). This third party can however not consent
or object to treatment.3 If a patient has clearly given an
advance directive while still competent, the treating physician is bound
to respect this (see advance directive).

To give
informed consent a patient needs to have mental capacity and the ability
to communicate.11 The physician needs to establish the patient’s
“ability to understand, retain, believe, evaluate, weigh and use information
that is relevant to a medical intervention or its withdrawal”.11
This test of capacity has been supported by several court rulings10,
12, 13 and is embedded in the Mental Capacity Act (2005).14

Making an
irrational choice does by no means constitute lack of capacity and a
competent patient’s irrational decision has to be accepted even if
this leads to an adverse outcome (including death).3

Mentally
ill patients

The Mental
Health Act (1983) regulates the treatment and hospital admission of
mentally ill patients not volunteering to undergo assessment and/or
treatment.15 These patients can only be admitted to hospital
if due to their mental illness they pose a threat to themselves or others.
Patients can be detained against their wishes to conduct an assessment
and if their condition is deemed treatable they can be detained to receive
such treatment. While this allows treatment for psychiatric conditions,
the treatment of physical conditions not related to mental illness cannot
be undertaken against the patient’s wishes. If needed, a court can
decide on treatment of non-psychiatric illnesses in those patients.

This aspect
of the law can leave physicians in difficult situations. If a depressed
patient takes an overdose of an anti-inflammatory drug he can be detained
in hospital using section 5.2 of the Mental Health Act. A resulting
medical complication like severe gastrointestinal bleeding is however
not covered by the mental health act. The patient therefore still remains
competent to refuse a life-saving endoscopy or blood transfusion.

Protecting
the public: infectious diseases, infection control and confidentiality

In order
to protect the public form contagious infectious diseases the Public
Health (Control of Disease) Act (1984) regulates notification of diseases
and mandatory treatment of conditions like tuberculosis (TB).16
The individual’s right to consent is severely restricted in two areas:
Firstly information about the patient’s diagnosis has to be given
to the relevant authorities. The patient should be informed about this
step. Section 11 regulates the disclosure of information. It is mandatory
for a medical practitioner to disclose personal details of the patient
and the diagnosis to the relevant authorities even if the patient does
not agree to this. The list of notify-able diseases ranges from food
poisoning and viral hepatitis to tuberculosis.

Secondly
patients suffering from communicable diseases can be forced to take
their medication by supervised administration or involuntary inpatient
treatment. Sections 37 and 38 of the Public Health (Control of Disease)
Act have recently been used to detain a man for inpatient treatment
of TB against his will at North Manchester General Hospital.17
The act was used to prevent the spread of TB to the wider public by
forcing treatment onto an individual, who was not compliant.

While above
regulations are clearly set out by law, a physician might encounter
situations in which no clear guidance is given. If a patient confesses
a crime or a planned crime to a doctor, it is left to him to decide
whether to pass on this information to the police. This decision requires
careful weighing up whether the right to consent on passing on information
is more important than the right of the public to be protected. GMC
guidance (Confidentiality: Protecting and Providing Information, 2004)
gives general advice on disclosure, but leaves the ultimate decision
with the medical practitioner.18

The legislative
has given clear laws stating when a right to consent does not apply
to a patient. Incompetent minors, adults lacking capacity and some mentally
ill patients do not have an absolute right to consent. Furthermore patients
suffering from some infectious diseases have limited right to consent
and can be detained and treated against their will. Using the principles
of capacity and justice towards other individuals the right to autonomy
has been cut in a few well-defined circumstances.

Advance
directives

When an
adult becomes incompetent he loses the right to decide on his medical
care. To allow patients to express their ideas and wishes before they
become incapacitated the Mental Capacity Act was introduced in 2005.19
Patients can give an advance directive or “living will” to outline
the treatments they wish or wish not to receive. A physician is required
to act within this advanced directive unless there is evidence that
the patient revoked the will when still competent. A “living will”
does not necessarily apply to all situations and it has to be checked
whether the patient’s current condition is covered by his will.

Practical
application of advance directives can be difficult: Unclear wording
like “no life-prolonging treatment” leaves room for interpretation
and the same intervention might have different outcomes depending on
underlying conditions. A healthy patient might set up an advance directive
to not receive mechanical ventilation without discussing the merits
of this intervention with a health care professional. This generally
prohibits any doctor from administering such treatment in any situation.
While this might be the patient’s wish should he suffer a devastating
stroke (very little chance of recovery), it could be argued that his
view would be different if the merits of ventilation after major emergency
surgery (reasonably good chance of full recovery) would have been explained
to him.

Furthermore
the act established the lasting power of attorney (LPA) concept. This
enables the patient to grant rights of consent and refusal to a LPA
while still competent. The LPA then takes over these powers when the
patient loses capacity.

Research
without consent

While consent
should always be sought for including patients in clinical research,
there are conditions that do not allow a delay: Unconscious patients,
patients in shock and studies with short therapeutic windows. While
including those patients without consent infringes their right to autonomy
society as a whole benefits from such research. The European Union (EU)
allows such studies to recruit patients without their consent under
strict regulation.20

The
right to refuse or demand treatment

British
law clearly gives competent patients the right to refuse any treatment
(the very few exceptions have been outlined in the chapter legal framework).
In contrast, however, no patient has a right to demand certain treatments.
GMC regulation (2008) states that if a patient wishes treatment that
in the doctor’s view is clinically not indicated there is no ethical
or legal obligation to provide such treatment.21

Burke, who
suffers from a chronic and progressing neurological illness, challenged
this guidance. He wishes to receive artificial nutrition and hydration
(ANH) when he loses his ability to swallow and he does not want doctors
to make decisions on his behalf. Arguing that the relevant GMC guidance
infringes his human rights he took the case to court achieving a favourable
ruling initially. Mr Justice Munby ruled in Burke22 that
the Human Rights Act (1998)23 entitles a person to demand
life-prolonging treatments such as ANH. He based his decision on article
2, 3 and 8 arguing that a competent person’s right to life and autonomy
constitute an entitlement to ANH.11

The Court
of Appeal overturned this ruling although the right-based analysis of
Munby’s decision was acknowledged. Two lines of argument were used
to justify the decision. Firstly the case of Bland24 (Airedale
NHS Trust 1993), an advance directive to withdraw treatment in a case
of persistent vegetative state must be respected, does not automatically
lead to a reverse decision in opposite cases.11

Secondly
an advanced directive demanding life-prolongueing treatment would not
be in consistence with the Mental Capacity Act, which requires the doctor
to take the incompetent patient’s best interest into consideration.11

Another
aspect of demanding treatment is the effect on the wider community.
Graber and Tansey argue that demanding certain (more expensive, equally
effective) treatments leads to injustice.25 While doctors
may feel pressured to please their patient’s wishes, financial and
organisational constraints in society (and a public health care system)
will mean that other patients might not get treatments they require.

Currently
there is no legal right in the UK to demand treatment. Furthermore such
demands infringe justice by prohibiting resources to be allocated by
need.

Practical
aspects of consent: understanding and retention of information provided

Informed
consent requires the ability to understand and weigh up information.
Several studies have addressed the issue of understanding and retention
of information provided. Even in a research setting where rigorous measures
for consent are applied severe defiencies have been identified: in a
randomized drug trial 44% of participants did not know that they were
assigned to treatment or placebo by chance.26 A capsule endoscopy
study recruited healthy volunteers, of whom 90% had university education
and 60% were medical students. Still vital information (drugs used,
potential risks) given during the consent was only completely recalled
by around 20%.27 These examples show that most patients or
research participants do not have a good understanding and/or recall
of the information provided by standard consent procedures. Despite
that treating doctors and researcher had treated or included patients
based on this “informed” consent.

Methods
like enhanced consent forms and multimedia interventions during informed
consent have shown mixed results, while only additional time spent in
one-on-one interviews significantly improved understanding and recall
of information.28

Discussion

Informed
consent is required for any investigation or treatment proposed to a
patient. Understanding of the nature of procedure, benefits and risks
are the cornerstones of informed consent. While autonomy is one of the
four main ethical principles, I argue that there is no absolute right
to autonomy or consent.

On a philosophical
basis an absolute right to autonomy and consent contradicts itself.

Several
restrictions in the right to consent are set by the legal framework
in the United Kingdom (or England). The main statuary instruments concerned
are: Mental Health Act, Mental Capacity Act and Public Health Act. UK
Law regulates the right to consent for minors, mentally ill patients,
patients with incapacity and patients with communicable diseases. Their
rights to consent are restricted and in special circumstances not granted.
Disclosure of information without consent is mandatory in infectious
diseases cases and legal in cases where the doctor believes that non-disclosure
will leave the public in danger. Furthermore patients can be recruited
to studies of emergency medical treatment without consent under strict
EU regulation. On a legal basis there is no absolute right to consent
therefore.

Patients
with anticipated incapacity can set advance directives to guide their
future treatment while still competent or a LPA can be given the right
to decide on treatment on the patient’s behalf. While this increases
the right of consent and improves patient autonomy to refuse treatment,
there is no right to demand treatment if this is considered medically
inappropriate (futile for example) by the treating medical practitioner.

Looking
at the practical aspects of consent shows that the information provided
is often poorly understood and retained. Patients giving consent are
doing so without being truly informed. In other words they can’t give
informed consent due to their lack of understanding. As shown in the
chapter practical aspects this will often not be noticed by the treating
doctor or researcher. It is difficult to conceive an absolute right
to consent in practice, when the effort to supply information required
for informed consent fails so often.

In summary
the patient’s right to autonomy should always be respected and step
shall be taken to make consent truly informed. On the basis of philosophical,
ethical, legal and practical considerations, however, there is no absolute
right to consent.